Trial Outcomes & Findings for A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants (NCT NCT05515601)
NCT ID: NCT05515601
Last Updated: 2024-07-05
Results Overview
PK: Cmax of mirikizumab was evaluated.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
396 participants
Primary outcome timeframe
Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdose
Results posted on
2024-07-05
Participant Flow
Participant milestones
| Measure |
200 Milligram (mg) Mirikizumab (Reference): Abdomen
Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL (milliliter) autoinjector administered as a subcutaneous (SC) injection into the abdomen on day 1.
|
200 mg Mirikizumab (Reference): Arm
Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm on day 1.
|
200 mg Mirikizumab (Reference): Thigh
Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the thigh on day 1.
|
200 mg Mirikizumab (Test): Abdomen
Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the abdomen on day 1.
|
200 mg Mirikizumab (Test): Arm
Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm on day 1.
|
200 mg Mirikizumab (Test): Thigh
Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the thigh on day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
63
|
69
|
67
|
66
|
66
|
65
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
63
|
69
|
67
|
66
|
66
|
65
|
|
Overall Study
COMPLETED
|
62
|
66
|
65
|
65
|
64
|
64
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
2
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
200 Milligram (mg) Mirikizumab (Reference): Abdomen
Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL (milliliter) autoinjector administered as a subcutaneous (SC) injection into the abdomen on day 1.
|
200 mg Mirikizumab (Reference): Arm
Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm on day 1.
|
200 mg Mirikizumab (Reference): Thigh
Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the thigh on day 1.
|
200 mg Mirikizumab (Test): Abdomen
Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the abdomen on day 1.
|
200 mg Mirikizumab (Test): Arm
Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm on day 1.
|
200 mg Mirikizumab (Test): Thigh
Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the thigh on day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
2
|
1
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Bioequivalence Study of Mirikizumab (LY3074828) in Healthy Participants
Baseline characteristics by cohort
| Measure |
200 mg Mirikizumab (Reference)
n=199 Participants
Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen on day 1.
|
200 mg Mirikizumab (Test)
n=197 Participants
Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen on day 1.
|
Total
n=396 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.7 years
STANDARD_DEVIATION 13.0 • n=39 Participants
|
41.1 years
STANDARD_DEVIATION 12.2 • n=41 Participants
|
40.9 years
STANDARD_DEVIATION 12.6 • n=35 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=39 Participants
|
104 Participants
n=41 Participants
|
202 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=39 Participants
|
93 Participants
n=41 Participants
|
194 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
36 Participants
n=39 Participants
|
33 Participants
n=41 Participants
|
69 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
163 Participants
n=39 Participants
|
164 Participants
n=41 Participants
|
327 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=39 Participants
|
6 Participants
n=41 Participants
|
17 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
29 Participants
n=39 Participants
|
30 Participants
n=41 Participants
|
59 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
150 Participants
n=39 Participants
|
152 Participants
n=41 Participants
|
302 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
199 Participants
n=39 Participants
|
197 Participants
n=41 Participants
|
396 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdosePopulation: All participants who received at least one dose of study drug (mirikizumab) and had evaluable PK data. Participants were excluded from the PK analysis set in the event of 1) a device malfunction, 2) administration of only 1 of the 2 x 1-mL autoinjector doses, or 3) administration of an incorrect or incomplete dose.
PK: Cmax of mirikizumab was evaluated.
Outcome measures
| Measure |
200 mg Mirikizumab (Reference)
n=196 Participants
Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen on day 1.
|
200 mg Mirikizumab (Test)
n=192 Participants
Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen on day 1.
|
|---|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab
|
13.0 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 42
|
12.9 micrograms per milliliter (μg/mL)
Geometric Coefficient of Variation 40
|
PRIMARY outcome
Timeframe: Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdosePopulation: All participants who received at least one dose of study drug (mirikizumab) and had evaluable PK data. Participants were excluded from the PK analysis set in the event of 1) a device malfunction, 2) administration of only 1 of the 2 x 1-mL autoinjector doses, or 3) administration of an incorrect or incomplete dose.
PK: AUC\[0-∞\] of Mirikizumab was evaluated.
Outcome measures
| Measure |
200 mg Mirikizumab (Reference)
n=195 Participants
Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen on day 1.
|
200 mg Mirikizumab (Test)
n=192 Participants
Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen on day 1.
|
|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC[0-∞]) of Mirikizumab
|
229 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 43
|
232 microgram*day per milliliter (μg*day/mL)
Geometric Coefficient of Variation 42
|
PRIMARY outcome
Timeframe: Predose on Day 1, Day 3, Day 5, Day 8, Day 11, Day 15, Day 22, Day 29, Day 43, Day 57, Day 71 and Day 85 postdosePopulation: All participants who received at least one dose of study drug (mirikizumab) and had evaluable PK data. Participants were excluded from the PK analysis set in the event of 1) a device malfunction, 2) administration of only 1 of the 2 x 1-mL autoinjector doses, or 3) administration of an incorrect or incomplete dose.
PK: AUC\[0-tlast\] of Mirikizumab was evaluated.
Outcome measures
| Measure |
200 mg Mirikizumab (Reference)
n=193 Participants
Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen on day 1.
|
200 mg Mirikizumab (Test)
n=187 Participants
Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm/thigh/abdomen on day 1.
|
|---|---|---|
|
PK: Area Under the Concentration Versus Time Curve From Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of Mirikizumab
|
225 μg*day/mL
Geometric Coefficient of Variation 42
|
231 μg*day/mL
Geometric Coefficient of Variation 41
|
Adverse Events
200 mg Mirikizumab (Reference): Abdomen
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
200 mg Mirikizumab (Reference): Arm
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
200 mg Mirikizumab (Reference): Thigh
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
200 mg Mirikizumab (Test): Abdomen
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
200 mg Mirikizumab (Test): Arm
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
200 mg Mirikizumab (Test): Thigh
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
200 mg Mirikizumab (Reference): Abdomen
n=63 participants at risk
Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the abdomen on day 1.
|
200 mg Mirikizumab (Reference): Arm
n=69 participants at risk
Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm on day 1.
|
200 mg Mirikizumab (Reference): Thigh
n=67 participants at risk
Participants received 200 mg mirikizumab reference formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the thigh on day 1.
|
200 mg Mirikizumab (Test): Abdomen
n=66 participants at risk
Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the abdomen on day 1.
|
200 mg Mirikizumab (Test): Arm
n=66 participants at risk
Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the arm on day 1.
|
200 mg Mirikizumab (Test): Thigh
n=65 participants at risk
Participants received 200 mg mirikizumab test formulation (100 mg/mL), 2 × 1-mL autoinjector administered as a SC injection into the thigh on day 1.
|
|---|---|---|---|---|---|---|
|
General disorders
Injection site reaction
|
15.9%
10/63 • Number of events 19 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
14.5%
10/69 • Number of events 19 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
17.9%
12/67 • Number of events 24 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
6.1%
4/66 • Number of events 7 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
9.1%
6/66 • Number of events 8 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
13.8%
9/65 • Number of events 16 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
3.2%
2/63 • Number of events 3 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
5.8%
4/69 • Number of events 4 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
3.0%
2/67 • Number of events 2 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
4.5%
3/66 • Number of events 3 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
10.6%
7/66 • Number of events 8 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
4.6%
3/65 • Number of events 3 • Baseline Up To 85 Days
All participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60